Myriad Lessons Learned
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Rinehart_production read v2 (clean) (Do Not Delete) 3/13/2016 7:14 PM Myriad Lessons Learned Amelia Smith Rinehart* Introduction ................................................................................................................... 1147 I. From Mendel to Myriad Genetics .......................................................................... 1149 A. A Brief History of Genes and Gene Hunting .................................... 1150 B. Myriad Genetics and BRCA Diagnostic Testing Commercialization .................................................................................. 1153 II. From Chakrabarty to Myriad .................................................................................... 1157 A. Patent Subject-Matter Eligibility ........................................................... 1158 B. Standing to Sue ........................................................................................ 1169 C. Evidence of Patent Impact .................................................................... 1174 III. From Myriad Onward ............................................................................................ 1178 A. Patent Law is Not Certain ..................................................................... 1181 B. Procedural Rules Can Have Substantive Impact ............................... 1185 C. Promote Progress Means More Than Incentivize ............................. 1186 Conclusion ...................................................................................................................... 1190 INTRODUCTION In June 2013, in Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad), the Supreme Court answered the provocative question, “Are human genes patentable?” with an equivocal, “Probably not.”1 Since then, a lot of ink has been spilled speculating on the impact of the decision, yet many questions remain unanswered for biotechnology companies, genetic researchers, and healthcare providers who must navigate its legal aftermath—what influence will Myriad have over the patent subject matter eligibility doctrine,2 how will Myriad impact * Associate Professor of Law, S.J. Quinney College of Law, University of Utah. I am grateful to Teneille Brown, Dan Burk, Jorge Contreras, Lincoln Davies, Andy Hessick, Carissa Hessick, Leslie Francis, Marc Rinehart, participants in the 2014 Rocky Mountain Junior Scholars conference, and participants in the present symposium, “The Meaning of Myriad,” for their helpful comments. Many thanks also to Danny Barber and Angela Silvers for their exemplary research assistance. Any errors are my own. 1. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2111 (2013). The Court held that isolated gene sequences are not patent eligible, even when removed from the body, but cDNA sequences, which are ostensibly man-made, are eligible for patenting. Id. 2. See, e.g., Timothy R. Holbrook & Mark D. Janis, Expressive Eligibility, 5 U.C. IRVINE L. REV. 973 (2015); Anna B. Laakmann, The New Genomic Semicommons, 5 U.C. IRVINE L. REV. 1001 (2015). 1147 Rinehart_production read v2 (clean) (Do Not Delete) 3/13/2016 7:14 PM 1148 UC IRVINE LAW REVIEW [Vol. 5:1147 investment decisions within the biotechnology industry,3 will Myriad Genetics, Inc.’s (Myriad) remaining patents and proprietary data successfully keep competitors at bay,4 and how might personalized cancer care change as a result?5 Although these questions are important, this Article does not promise to answer them. Instead, it presents the Myriad saga as a cautionary patent tale, one that explores a more fundamental question: How can patent law, in the words of Benjamin Cardozo, “mediate between the conflicting claims of stability and progress”?6 The Myriad story began long before the Myriad plaintiffs filed suit in 20097 and even before Myriad and others raced to discover the genes linked to hereditary breast cancer in 1994.8 In 1980, the Supreme Court in Diamond v. Chakrabarty confirmed the patent eligibility of biological organisms.9 In doing so, the Court welcomed an exciting new field of biotechnology to play by the existing patent rules. As Myriad won the race to isolate and sequence the breast cancer genes, obtained patent protection over them, enforced its patents against others, built and monopolized a market for diagnostic tests, and, finally, defended its patents against challenges, it did so within, not outside of, the confines of patent law. The commercialization of breast cancer diagnostic testing, chronicled from Chakrabarty to Myriad, demonstrates how stability within patent law’s eligibility doctrine, a limited ability to challenge gene patents despite vocal critics, and the strength of 3. One early account indicates minimal impact on biotechnology investment overall, in light of technological advancements. See Howard Wolinsky, Gene Patents and Capital Investment, 14 EUR. MOLECULAR BIOLOGY ORG. REP. 871 (2013). 4. Soon after the Court’s decision, Myriad filed suit against new entrants, some of which sued Myriad for declaratory relief in other jurisdictions. The Judicial Panel on Multidistrict Litigation consolidated these in the District of Utah. Order Granting Motion to Transfer and Consolidate, In Re BRCA1 and BRCA2-Based Hereditary Cancer Test Patent Litig., No. 2:14-CV-2510 (D. Utah July 7, 2014). Myriad is the co-owner or exclusive licensee of the patents in both Myriad and the newer litigations, and Myriad commercialized the diagnostic tests at issue in Myriad. This Article refers to Myriad as the patent owner, and this designation indicates its ability to control the patent rights to exclude others including other joint owners. See Vaupel Textilmaschinen KG v. Meccanica Euro Italia S.P.A., 944 F.2d 870, 875–76 (Fed. Cir. 1991) (holding that an exclusive licensee possesses all of the substantial rights in a patent). 5. Kenneth Offit et al., Gene Patents and Personalized Cancer Care: Impact of the Myriad Case on Clinical Oncology, 31 J. CLINICAL ONCOLOGY 2743, 2743 (2013) (“[W]e will suggest that the outcome of [Myriad] will likely not have a large immediate impact for oncologic care of patients . [but] may have a larger long-term impact on the role of intellectual property protection in modern genomic and medical science.”). 6. BENJAMIN CARDOZO, THE GROWTH OF THE LAW 1 (1924). Cardozo, of course, referred to progress in the law, not progress of technology, as the patent system is meant to promote. See U.S. CONST. art. I, § 8, cl. 8. This Article discusses progress along both dimensions, and often refers to growth in the law to indicate legal progress, as compared to technological progress. 7. See Complaint, Ass’n for Molecular Pathology v. USPTO, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (No. 09-4515). 8. See Yoshio Miki et al., A Strong Candidate for the Breast and Ovarian Cancer Susceptibility Gene BRCA1, 266 SCIENCE 66 (1994); Richard Wooster et al., Identification of the Breast Cancer Susceptibility Gene BRCA2, 378 NATURE 789 (1995). 9. See Diamond v. Chakrabarty, 447 U.S. 303, 309–10 (1980). Rinehart_production read v2 (clean) (Do Not Delete) 3/13/2016 7:14 PM 2015] MYRIAD LESSONS LEARNED 1149 gene patents to exclude others within markets like those for diagnostic testing converged to slow progress within the law. This resulted in a commercial monopoly based upon later-invalidated patents and unintended consequences for all stakeholders. This Article explores the Myriad case as an illustration of patent law’s unremitting struggle to mediate between stability and progress. Part I describes the scientific and commercialization background necessary for understanding the Myriad litigation. Part II examines the patent-eligibility doctrine through the lens of Myriad and the doctrine of standing as it related to the Myriad plaintiffs. Part II also discusses how Myriad’s patents enabled it to monopolize the market for commercial breast cancer diagnostic testing in the United States and the consequences (perceived and real) for genetic researchers, healthcare professionals, and their patients. Part III tells the Myriad story as one of slow progress in the law with many important and lasting effects. It offers several suggestions that might mitigate the mistake of relying too heavily on patent law stability at the cost of progress of both law and technology, especially in light of ever-changing social, scientific, and economic realities, as demonstrated in Myriad itself. I. FROM MENDEL TO MYRIAD GENETICS In a May 14, 2013, op-ed in the New York Times, Angelina Jolie, the actress and humanitarian, announced that she had undergone a preventive double mastectomy after testing positive for BRCA1, a gene linked to an exceedingly high risk of breast and ovarian cancer.10 Discussing the diagnostic testing that she received, Jolie wrote: Breast cancer alone kills some 458,000 people each year . mainly in low- and middle-income countries. It has got to be a priority to ensure that more women can access gene testing and lifesaving preventive treatment, whatever their means and background, wherever they live. The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women.11 Jolie did not identify the provider of her diagnostic test, nor did she weigh in on the merits of gene patenting—her message encouraged women to gather information, learn more about incidences within a patient’s own family, and, when appropriate, get individualized testing.12 Nevertheless, as shown by the tremendous public interest taken in Jolie’s